1-1 By: Hamric, McCall, et al. (Senate Sponsor - Shapiro) H.B. No. 63
1-2 (In the Senate - Received from the House March 22, 1993;
1-3 March 23, 1993, read first time and referred to Committee on Health
1-4 and Human Services; April 14, 1993, reported adversely, with
1-5 favorable Committee Substitute by the following vote: Yeas 9, Nays
1-6 0; April 14, 1993, sent to printer.)
1-7 COMMITTEE VOTE
1-8 Yea Nay PNV Absent
1-9 Zaffirini x
1-10 Ellis x
1-11 Madla x
1-12 Moncrief x
1-13 Nelson x
1-14 Patterson x
1-15 Shelley x
1-16 Truan x
1-17 Wentworth x
1-18 COMMITTEE SUBSTITUTE FOR H.B. No. 63 By: Nelson
1-19 A BILL TO BE ENTITLED
1-20 AN ACT
1-21 relating to the regulation of mammography devices and the practice
1-22 of mammography.
1-23 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-24 SECTION 1. Chapter 401, Health and Safety Code, is amended
1-25 by adding Subchapter L to read as follows:
1-26 SUBCHAPTER L. CERTIFICATION OF MAMMOGRAPHY SYSTEMS
1-27 Sec. 401.421. DEFINITIONS. In this subchapter:
1-28 (1) "Certification" means an authorization for the use
1-29 of a mammography system.
1-30 (2) "Mammography" means the use of radiation to
1-31 produce an image of the breast on film, paper, or digital display
1-32 that may be used to detect the presence of pathological conditions
1-33 of the breast.
1-34 (3) "Mammography system" includes the following:
1-35 (A) an x-ray unit used as a source of radiation
1-36 in producing images of breast tissue;
1-37 (B) an imaging system used for the formation of
1-38 a latent image of breast tissue;
1-39 (C) an imaging processing device for changing a
1-40 latent image of breast tissue to a visual image that can be used
1-41 for diagnostic purposes;
1-42 (D) a viewing device used for the visual
1-43 evaluation of an image of breast tissue if the image is produced in
1-44 interpreting visual data captured on an image receptor;
1-45 (E) a medical radiological technologist who
1-46 performs a mammography; and
1-47 (F) a physician who engages in, and who meets
1-48 the requirements adopted by board rule relating to, the reading,
1-49 evaluation, and interpretation of mammograms.
1-50 Sec. 401.422. CERTIFICATION REQUIRED. (a) A person may not
1-51 perform mammography unless the mammography system used has been
1-52 issued a certification under this subchapter.
1-53 (b) A certification under Subsection (a) is required in
1-54 addition to any license, registration, or other requirement under
1-55 this chapter.
1-56 Sec. 401.423. POWERS AND DUTIES OF BOARD. (a) The board
1-57 shall:
1-58 (1) prescribe application forms for original and
1-59 renewal certifications;
1-60 (2) adopt rules for the administration of this
1-61 subchapter; and
1-62 (3) take other action necessary to enforce this
1-63 subchapter.
1-64 (b) The board shall apply under the Mammography Quality
1-65 Standards Act of 1992 (42 U.S.C. Section 354) to carry out the
1-66 certification program requirements and to implement the standards
1-67 established by the United States Secretary of Health under that Act
1-68 in this state. If the United States Secretary of Health grants the
2-1 board's application, the board shall assume those responsibilities.
2-2 Sec. 401.424. MAMMOGRAPHY CERTIFICATION STANDARDS. (a) To
2-3 receive a mammography certification under this subchapter, the
2-4 mammography system must, at a minimum:
2-5 (1) meet criteria at least as stringent as the
2-6 American College of Radiology mammography accreditation program;
2-7 (2) be specifically designed and used for the
2-8 performance of mammography;
2-9 (3) be operated by an individual certified as a
2-10 medical radiologic technologist under Chapter 1096, Acts of the
2-11 70th Legislature, Regular Session, 1987 (Article 4512m, Vernon's
2-12 Texas Civil Statutes), who has successfully completed special
2-13 training in mammography; and
2-14 (4) be used in a facility that:
2-15 (A) meets, at minimum, the requirements for
2-16 certification of the Mammography Quality Standards Act of 1992 (42
2-17 U.S.C. Section 354);
2-18 (B) has a licensed medical physicist specialized
2-19 in radiology under Chapter 235, Acts of the 72nd Legislature,
2-20 Regular Session, 1991 (Article 4512n, Vernon's Texas Civil
2-21 Statutes), who at least annually provides on-site consultation to
2-22 the facility including a complete evaluation of the entire
2-23 mammography system to ensure compliance with this subchapter;
2-24 (C) maintains records of the consultations
2-25 required under Paragraph (B) for not less than seven years after
2-26 the date the consultation was performed;
2-27 (D) establishes a quality control program that
2-28 meets requirements that are at least as stringent as those of the
2-29 American College of Radiology mammography accreditation program;
2-30 and
2-31 (E) maintains and makes available to a patient
2-32 of the facility original mammograms performed at the facility until
2-33 the earlier of:
2-34 (i) the fifth anniversary of the
2-35 mammography;
2-36 (ii) if an additional mammogram of the
2-37 same patient is not performed by the facility, the 10th anniversary
2-38 of the mammography; or
2-39 (iii) at the request of the patient, the
2-40 patient's medical records are forwarded to another medical
2-41 institution.
2-42 (b) To protect the public health, the board by rule may
2-43 adopt more stringent or additional requirements for:
2-44 (1) the certification of mammography systems; and
2-45 (2) the retention of original mammograms.
2-46 (c) To protect the public health, the board by rule shall
2-47 adopt qualifications for a physician who reads, evaluates, and
2-48 interprets a mammogram that are no less stringent than the
2-49 standards of the American College of Radiology.
2-50 (d) The board shall make available to the public copies of
2-51 the criteria of the American College of Radiology mammography
2-52 accreditation program or the modified criteria adopted by board
2-53 rule.
2-54 (e) Notwithstanding any other provision of this chapter, the
2-55 standards imposed for certification under this chapter may not be
2-56 less stringent than the standards imposed on a facility under the
2-57 Mammography Quality Standards Act of 1992 (42 U.S.C. Section 354).
2-58 Sec. 401.425. ALTERNATIVE CERTIFICATION; EXEMPTIONS.
2-59 (a) The department shall issue a certification under this
2-60 subchapter for a mammography system for which the department is
2-61 provided proof of accreditation by the American College of
2-62 Radiology or another recognized organization that has standards no
2-63 less stringent than the standards of the American College of
2-64 Radiology.
2-65 (b) A mammography system issued a certification under this
2-66 section is exempt from the certification standards established by
2-67 or under Section 401.424 and the inspection requirements
2-68 established by or under Section 401.430.
2-69 (c) If the board finds that application of this section
2-70 would make the requirements of this chapter less stringent than the
3-1 standards applicable under the Mammography Quality Standards Act of
3-2 1992 (42 U.S.C. Section 354), the board may not issue a
3-3 certification under this section.
3-4 Sec. 401.426. APPLICATION FOR CERTIFICATION. (a) A person
3-5 who owns, leases, or uses or the agent of a person who owns,
3-6 leases, or uses a mammography system must file a written
3-7 application for certification under Section 401.424 or Section
3-8 401.425 on a form prescribed by the board.
3-9 (b) The department may require, at any time after an
3-10 application is filed, further information from the applicant and
3-11 conduct inspections necessary to determine whether the application
3-12 for certification should be granted or denied.
3-13 Sec. 401.427. CERTIFICATION RENEWAL. (a) A certification
3-14 is valid for one year and may be renewed annually on payment of the
3-15 required renewal fee.
3-16 (b) The board by rule may adopt a system under which
3-17 certifications under this subchapter expire on various dates during
3-18 the year.
3-19 (c) If a certification holder fails to renew the
3-20 certification by the required date, the certification holder may
3-21 renew the certification on payment of the renewal fee and a late
3-22 fee set by the board. If the certification is not renewed before
3-23 the 181st day after the date on which the certification expired,
3-24 the certification holder must apply for an original certification
3-25 under this subchapter.
3-26 (d) A mammography system may not be used after the
3-27 expiration date of the certification unless the holder of the
3-28 expired certification has made a timely and sufficient application
3-29 for renewal of the certification as provided under Section 18,
3-30 Administrative Procedure and Texas Register Act (Article 6252-13a,
3-31 Vernon's Texas Civil Statutes), and a final determination of the
3-32 application by the board has not been made.
3-33 Sec. 401.428. DENIAL, SUSPENSION, REVOCATION, OR
3-34 REINSTATEMENT OF CERTIFICATION. (a) The department may deny,
3-35 suspend, revoke, or reinstate a certification.
3-36 (b) The board shall adopt rules establishing the grounds for
3-37 denial, suspension, revocation, or reinstatement of a certification
3-38 and establishing procedures for disciplinary actions.
3-39 (c) Proceedings relating to the suspension or revocation of
3-40 a certification issued under this subchapter are subject to the
3-41 Administrative Procedure and Texas Register Act (Article 6252-13a,
3-42 Vernon's Texas Civil Statutes).
3-43 (d) A person whose certification has been revoked may apply
3-44 for a new certification on the expiration of one year after the
3-45 date the certification was revoked.
3-46 Sec. 401.429. CERTIFICATION FOR MULTIPLE MAMMOGRAPHY
3-47 SYSTEMS. (a) An applicant for certification under Section 401.426
3-48 must obtain a separate certification for each mammography system
3-49 that is owned, leased, or used by the applicant.
3-50 (b) Certification of multiple mammography systems by a
3-51 single applicant may be recorded on a single certification
3-52 document. If multiple mammography systems are recorded on a single
3-53 certification document, each specific machine certified, if any,
3-54 must be identified on the certification document by referring to
3-55 the machine's manufacturer, model number, and serial number.
3-56 Sec. 401.430. INSPECTIONS. (a) The department shall
3-57 inspect each mammography system that receives a certification under
3-58 this subchapter not later than the 60th day after the date the
3-59 certification is issued.
3-60 (b) The department shall inspect, at least once annually,
3-61 each mammography system that receives a certification.
3-62 (c) To protect the public health, the department may conduct
3-63 more frequent inspections than required under this section.
3-64 (d) The department shall make reasonable attempts to
3-65 coordinate inspections under this section with other inspections
3-66 required under this chapter for the facility where the mammography
3-67 system is used.
3-68 (e) After each satisfactory inspection, the department shall
3-69 issue a certificate of inspection for each mammography system
3-70 inspected. The certificate of inspection must be posted at a
4-1 conspicuous place on or near the place where the mammography system
4-2 is used. The certificate of inspection shall:
4-3 (1) specifically identify the mammography system
4-4 inspected;
4-5 (2) state the name and address of the facility where
4-6 the mammography system was used at the time of the inspection; and
4-7 (3) state the date of the inspection.
4-8 (f) A notice of a mammography system's failure to satisfy
4-9 department standards shall be posted:
4-10 (1) on the mammography system at a conspicuous place
4-11 if the system is a machine; or
4-12 (2) near the place where the mammography system
4-13 practices if the system is an individual.
4-14 (g) To protect the public health, the board may adopt rules
4-15 concerning the grounds for posting a failure notice and the
4-16 placement and size of the failure notice.
4-17 Sec. 401.431. TRANSITION. (a) A mammography system is not
4-18 required to have a certification under this subchapter until
4-19 July 1, 1994.
4-20 (b) Section 401.422 takes effect July 1, 1994.
4-21 (c) The board shall adopt rules under this subchapter not
4-22 later than January 1, 1994.
4-23 (d) This section expires January 1, 1996.
4-24 SECTION 2. The importance of this legislation and the
4-25 crowded condition of the calendars in both houses create an
4-26 emergency and an imperative public necessity that the
4-27 constitutional rule requiring bills to be read on three several
4-28 days in each house be suspended, and this rule is hereby suspended,
4-29 and that this Act take effect and be in force from and after its
4-30 passage, and it is so enacted.
4-31 * * * * *
4-32 Austin,
4-33 Texas
4-34 April 14, 1993
4-35 Hon. Bob Bullock
4-36 President of the Senate
4-37 Sir:
4-38 We, your Committee on Health and Human Services to which was
4-39 referred H.B. No. 63, have had the same under consideration, and I
4-40 am instructed to report it back to the Senate with the
4-41 recommendation that it do not pass, but that the Committee
4-42 Substitute adopted in lieu thereof do pass and be printed.
4-43 Zaffirini,
4-44 Chair
4-45 * * * * *
4-46 WITNESSES
4-47 FOR AGAINST ON
4-48 ___________________________________________________________________
4-49 Name: Jim Zukowski x
4-50 Representing: Tx Dept. of Health
4-51 City: Austin
4-52 -------------------------------------------------------------------
4-53 Name: Linda Farrow x
4-54 Representing: Tx Dept. of Health
4-55 City: Austin
4-56 -------------------------------------------------------------------
4-57 Name: Emily Untermeyer x
4-58 Representing: Tx Cancer Council
4-59 City: Austin
4-60 -------------------------------------------------------------------
4-61 Name: Sara Rusk McGonagle x x
4-62 Representing: Tx Nurses Assn.
4-63 City: Austin
4-64 -------------------------------------------------------------------
4-65 Name: Janie McMahan x x
4-66 Representing: Tx Hospital Assn.
4-67 City: Austin
4-68 -------------------------------------------------------------------
4-69 FOR AGAINST ON
4-70 ___________________________________________________________________
5-1 Name: Cindy Antolik x x
5-2 Representing: American Cancer Society
5-3 City: Austin
5-4 -------------------------------------------------------------------
5-5 Name: Lisa McGiffert x x
5-6 Representing: Consumers Union
5-7 City: Austin
5-8 -------------------------------------------------------------------
5-9 Name: Gerald D. Dodd, M.D. x
5-10 Representing: Tx Radiological Society
5-11 City: Houston
5-12 -------------------------------------------------------------------
5-13 Name: Joseph Nanus x
5-14 Representing: Tx Dept. of Health
5-15 City: Austin
5-16 -------------------------------------------------------------------
5-17 Name: Janet A. Hale, M.D. x
5-18 Representing: Tx Medical Assn.
5-19 City: Dallas
5-20 -------------------------------------------------------------------
5-21 Name: David Smith, M.D. x
5-22 Representing: Tx Dept. of Health
5-23 City: Austin
5-24 -------------------------------------------------------------------
5-25 Name: Anne Crews x
5-26 Representing: Susan Komen Foundation
5-27 City: Dallas
5-28 -------------------------------------------------------------------
5-29 Name: Lucretia Biscomb x x
5-30 Representing: Self
5-31 City: Round Rock
5-32 -------------------------------------------------------------------